Surgical drape and panel assembly

ABSTRACT

A disposable surgical drape for use in cardiovascular surgical procedures which may optionally be used to isolate a sterile pumping mechanism from a non-sterile pump driving mechanism and/or provide support for medical equipment, such as medical tubing.

RELATED APPLICATIONS

This application is a continuation of co-pending patent application Ser.No. 10/445,639 filed 27 May 2003, which is a continuation of abandonedpatent application Ser. No. 09/729,740 filed 4 Dec. 2000, which claimsthe benefit under Title 35, United States Code, §110(e) of U.S.Provisional Application No. 60/168,795 filed on Dec. 2, 1999 andentitled “Surgical Drape and Panel Assembly.”

BACKGROUND OF THE INVENTION

I. Field of the Invention

The present invention relates generally to surgical drapes. Moreparticularly, the present invention relates to a disposable surgicaldrape for use in cardiovascular surgical procedures which advantageouslymaintains sterile and clean conditions at an operation site and mayoptionally be used to isolate a sterile pumping mechanism from anon-sterile pump driving mechanism and/or provide support for medicalequipment used during cardiovascular procedures.

II. Discussion of the Prior Art

Surgical drapes are well known in the medical community. Generallyspeaking, surgical drapes are designed to prevent contamination of thesterilized operative site. The need for surgical drapes stems from theinherent risk for infection during surgical procedures. Morespecifically, bacteria on the patient's skin and/or from unsterilizedequipment may infect the surgical site. In order for the bacteria toinfect the wound, it must be transferred by a medium such as airborneparticles, fluids, lint, dust particles or skin particles originatingfrom the surgeon or patient or any other staff in the operating theatre.

A wide variety of surgical drapes have been developed in the prior artto improve sterility at the operative site. In certain applications,multiple drapes are employed to reduce the possibility of infection,including the use of a surgical drape deployed about the head/neckregion of the patient. In this fashion, surgical support staff (such asa perfusionist) may be positioned on the non-surgical side of the drapepartition while the surgical team operates within the sterile field onthe other side of the surgical drape.

There are two main types of surgical drapes: disposable and reusable.Disposable surgical drapes are typically constructed of multiple layers,with one layer having absorbent properties and another layer that isimpervious to fluids. In this fashion, the disposable surgical drapeprovides both absorbency and a bacterial barrier.

Reusable surgical drapes are typically constructed of cotton fabric.Cotton surgical drapes are advantageous in that, during a surgicalprocedure, any spilled fluids will be readily absorbed by the drape. Aswill be appreciated, this eliminates the fluid as a transport medium forbacteria. However, bacteria may nonetheless pass through the fibersforming the cotton drape, and fibers may become detached from the drape,presenting the possibility for bacteria to enter the operative site. Toavoid this problem, the drapes have been constructed from apolyester-cotton mixture treated with a liquid repellant finish. Whilean improvement, these newer cotton-based surgical drapes werenonetheless flawed in that the finish loses its liquid repellantcharacteristics over time. Another drawback to cotton-based surgicaldrapes is that they are predisposed to produce lint, which therebyprovides a transport medium for the bacteria. Moreover, the productionof lint increases after each use and reuse.

During surgical procedures, a second drape may be employed as apartition to separate the sterile surgical site from a non-sterile zoneoutside the field of surgery. When deployed about the patient's headand/or neck, such a drape is referred to as an “anesthesiologist screen”because it separates the non-sterile area where the anesthesiologistsits during surgery from the sterile surgical area below the patient'shead and neck. Anesthesiologists typically monitor and seek to controlsuch patient characteristics as blood gas, lung ventilation, bodytemperature, and evacuation of fluids.

In cardiopulmonary bypass (CPB) procedures, the anesthesiologist is alsoresponsible for establishing and monitoring the bypass circuit. CPBsurgery involves the use of a blood pump to remove and return blood fromthe patient's body through cannulas and tubing placed within thepatient's circulatory system. The outflow cannula is connected to ablood pump, such as the one disclosed in U.S. Pat. No. 5,746,575 titled“Blood Pump as Centrifugal Pump,” the disclosure of which is herebyexpressly incorporated by reference. The blood pump is driven throughthe use of a motor that is magnetically coupled to the blood pump.Typically, the motor used to drive the blood pump is not sterilizablesuch that the motor must be positioned outside the sterile surgicalfield. By placing the blood pump and motor outside the sterile field,long lengths of surgical tubing must be utilized to connect the bloodpump to the cannula. This additional medical tubing increases thepriming volume of the CPB circuit and may also increase hemolysis basedon the exposure to a greater amount of foreign surface area, i.e. thetubing.

To establish a CPB circuit, medical tubing is passed from the sterilesurgical site, under the anesthesiologist screen, for connection to theblood pump and motor driving unit located in the non-sterile region. Theanesthesiologist must de-air the system to ensure no air emboli willform in the patient's blood system. After de-airing the system, thetubing is connected to a blood pump, which the anesthesiologist controlswith an associated pump control and monitoring system. Throughout theentire procedure, the surgeon must relay control commands to theanesthesiologist and rely upon these communications. The surgeon istypically unable to view the pump or control panel at any time duringthe procedure.

The CPB circuit described above, while very common in use, isnonetheless flawed in several significant ways. First, this prior artCPB circuit is undesirable because it increases the amount of foreignmaterial that the blood is in contact with, thereby increasing thelikelihood of hemolysis. This is due to the need to place the blood pumpand motor outside the sterile surgical field. The blood must also befurther treated with heparin to reduce the natural clotting that occursas the result of contact between the blood and the foreign material ofthe CPB circuit. Another significant drawback of the CPB system of theprior art is that the pump and motor are necessarily placed outside thesterile surgical field (due to the inability to sterilize the motor).With the pump and motor outside sterile surgical field and thus outsidethe surgeon's field of view, a second person must be present within theoperating room to monitor and control the pump and driving motor. Thisdisadvantageously clutters the operating room. Moreover, the informationdisplayed on the CPB equipment must be relayed to the surgeon, therebyfurther complicating the procedure.

The present invention is directed at overcoming, or at least reducingthe effects of, one or more of the problems set forth above.

SUMMARY OF THE INVENTION

The present invention addresses the shortcomings of the prior artsurgical drapes by providing a sterile barrier having a support panelparticularly adapted for use in cardiovascular procedures. The surgicaldrape and panel assembly advantageously provides the ability to positiona sterile blood pump within the sterile surgical field, thereby reducingthe CPB circuit and freeing up valuable space around the head and neckregion of the patient. This allows the perfusionist more room to performtheir work.

The present invention generally relates to a surgical drape having amechanism for disposing a blood pump therethrough or about. The surgicaldrape has defined sections, which allow the surgeon to pass a sterilepump drive cable therethrough, thereby isolating the non-sterile drivingmechanism (i.e. motor) from the sterile pump assembly located within thesurgical field. Further, the drape may include areas specificallydesigned to be placed between the coupling between the sealed pumpingmechanism and the driving motor.

By utilizing the present invention, the surgeon may place the sterilepump closer to the surgical site, thereby reducing the amount of foreigntubing that is necessary to connect the blood pump to the cannulasplaced within the patient's vascular system. A further advantage of theinvention is that the pump, driving mechanism, and control panel may belocated at a distance closer to the surgeon, thereby enabling thesurgeon to view the information more readily. The driving mechanism andcontrol panel may be located near the patient's head, thereby allowingthe perfusionist closer monitoring of the pump system and the patient'svital signs.

In one embodiment of the present invention, the surgical drape isdesigned such that it is to be disposed adjacent to the patient's headregion. The surgical drape is sufficiently thin so as to allow thesurgeon to couple a sterile blood pump to a non-sterile drivingmechanism without interfering with the clamping mechanism.

In another embodiment the surgical drape further contains apertureswhich allow sterile materials to be passed through from the surgicalsite, to the non-sterile surgical site adjacent to the patient's headarea. Thereby allowing a sterile pump to be placed closer to thesurgical site while the non-sterile driving mechanism is placed outsidethe sterile surgical field. Thus further reducing the amount of foreigntubing used to connect the blood pump to the patient's vascular system.

In another embodiment, the surgical drape further comprises a rigidpanel disposed about the head/neck region of the patient, whereby thepanel is adapted to receive a blood pump and associate tubing during asurgical procedure.

In another embodiment the surgical drape of the present inventionfurther comprises a clear viewing portion thereby allowing thesurgeon/anesthesiologist look through the drape instead of having tomove around the drape.

In another embodiment, the rigid panel structure further containsconnectors for various medical devices utilized during a surgicalprocedure. Thus, by utilizing the panel and the connections containedthereon the surgeon is better able to organize the surgical field.

BRIEF DESCRIPTION OF THE DRAWINGS

Many advantages of the present invention will be apparent to thoseskilled in the art with a reading of this specification in conjunctionwith the attached drawings, wherein like reference numerals are appliedto like elements and wherein:

FIG. 1 is an illustration of the surgical drape of the presentinvention;

FIG. 2 is a front view of the surgical drape;

FIG. 3 is a perspective view of the surgical drape and panel of thepresent invention;

FIG. 4 is a side view of the panel/drape of the present invention;

FIG. 5 is a cross-sectional view of the surgical drape of the presentinvention;

FIG. 6 is a top view of the motor;

FIG. 7 is a side view of the panel illustrating the pump and motor ofthe present invention;

FIG. 8 is a perspective view of the panel of the present invention;

FIG. 9 is a front view of the panel of the present invention; and

FIG. 10 is a perspective view illustrating various features of thepresent invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Illustrative embodiments of the invention are described below. In theinterest of clarity, not all features of an actual implementation aredescribed in this specification. It will of course be appreciated thatin the development of any such actual embodiment, numerousimplementation-specific decisions must be made to achieve thedevelopers' specific goals, such as compliance with system-related andbusiness-related constraints, which will vary from on implementation toanother. Moveover, it will be appreciated that such a development effortmight be complex and time-consuming, but would nevertheless be a routineundertaking for those of ordinary skill in the art having the benefit ofthis disclosure.

Referring now to the drawings, there is shown a preferred embodiment ofa surgical drape in accordance with the present invention. The drape isparticularly suited for use during cardiovascular procedures where ablood pump is utilized or for any other surgical procedures utilizingcoupled devices that consist of sterile and non-sterile portions.

As illustrated in FIG. 1, surgical drape 10 is generally rectangular andis formed of a flexible material of sufficient size such that surgicaldrape 10 may be utilized as a screen between the surgical field and theanesthesiologist. Surgical drape 10 comprises of first surface 15 andsecond surface 17. During use, first surface 15 is disposed facing thesterile surgical zone and second surface 17 faces the non-sterile area.

As illustrated in FIGS. 2 and 3, surgical drape 10 may further containaperture(s) 25 disposed therethrough. In use, aperture 25 may be used topass surgical devices through the drape from the sterile surgical sideto the non-sterile area. As illustrated in FIG. 1, the physician canpass tubing through aperture 25, which may then be connected to a bloodpump located outside the sterile field. Alternatively, as shown in FIG.3, a sterile pump drive cable 230 can be passed through aperture 25 andconnected to a motor (not shown) within the non-sterile surgical fieldand a pump 200 located within the sterile surgical field.

As shown in FIG. 2, aperture 25 may further contain a sterile sleeve 60,which may be disposed about a medical device that is passed through theaperture 25. The sterile sleeve 60 may by utilized where a steriledevice has been passed through to the non sterile side, therebyrendering it non-sterile, though at some time during the procedure itmay be necessary to move the device from the non-sterile side back intothe sterile surgical field. In order to do so, sleeve 60 may be disposedabout the device so that the non-sterile device is encapsulated withinthe interior of sleeve 60. Therefore, the non-sterile device may bebrought back into the sterile surgical field because the sleeve 60protected the device from contamination while in the non-sterile field.

As illustrated in FIG. 2, aperture 25 and sleeve 60 are initiallycovered by membrane 40, which is attached to the first surface 15 orsecond surface 17 of drape 10. Membrane 40 may be disposed aboutaperture 25 such that membrane 40 reinforces the edges of the aperture25. This reinforcement provides further protections against tearing orabrasion about aperture 25 and drape 10. Prior to using aperture 25, theuser must first open aperture 25 by tearing the perforations 41 that aredisposed within the surgical drape 10. The perforations 41 facilitatethe controlled tearing of the drape when desired.

Surgical drape 10, which may compromise any flexible disposable woven,non-woven, or plastic material, has a first surface 15 and secondsurface 17. As used within this disclosure, it should be understood thatthe second surface 17 will be in contact with the patient's body ifdrape 10 is utilized to cover the patient's body during surgicalprocedures. Alternatively, if drape 10 is utilized as a screen betweenthe patient's body and the anesthesiologist/perfusionist, then it shouldbe understood that the second surface 17 will be facing theanesthesiologist as illustrated in FIG. 1, while the first surface 15 ofdrape 10 will face away from the anesthesiologist. Drape 10 ispreferably constructed of a non woven material which has been treated tomake it repellent to liquids such as water, alcohol, blood, saline, orany other fluid that may be encountered during a surgical procedure.Surgical drape 10 may be formed of a single piece of material or may beformed of a plurality of pieces that are permanently bonded together.Alternatively, the surgical drape of this invention may be formed ofmultiple layers.

As shown in FIG. 5, the first layer 11 is permeable and allows fluid topass therethrough. The second layer 12 is constructed of an absorbentmaterial which absorbs the fluid that is allowed to pass through thefirst layer 11. The third layer 13 is constructed of an imperviousmaterial, therefore any fluids that come into contact with the drapeduring a surgical procedure will be absorbed by the second layer 12 ofthe drape 10 and not contact the skin of the patient. Alternatively, thesurgical drape 10 of the present invention may be formed of two layers(not shown). An upper absorbent layer 12 and a lower impermeable layer13 thereby lessening the cost of manufacture and the overall bulk of thedrape.

As illustrated in FIGS. 1 and 3, in use, surgical drape 10 may beutilized as a screen between the head and neck region of the patient. Asmentioned previously, surgical drape 10 is particularly suited for usein cardiovascular procedures and is preferably sufficiently long, notonly to be utilized as an anesthesia screen but also to cover the bodyof the patient. As illustrated in FIG. 3, a sterile blood pump 200 maybe placed within the sterile operating field while the flexible drive230 cable is passed through the aperture 25 and connected to a motor 250(not shown) disposed on the non-sterile side. This arrangement isparticularly useful in that it allows a sterile pump to be placed withinthe surgical field, thereby lessening the priming volume of the bypasscircuit.

With combined reference to FIGS. 3 and 8-10 surgical drape 10 mayfurther comprise panel 70. Panel 70 is adapted to be disposed adjacentto or about the patient's head during surgical procedures. Panel 70 isadapted to receive and retain a blood pump 200, a blood reservoir (notshown), a blood filter (not shown), or a blood oxygenator 300, eithersingly or in any combination thereof. As shown in FIGS. 6 and 7, bloodpump assembly 280 comprises a sterile pump 200 and a non-sterile motor250. The non-sterile motor 250 contains bore 255 dimensioned to receivethe sterile pump 200.

As shown in FIG. 7, panel 70 contains annular groove 73 dimensioned toreceive coupling member 256. Coupling member 256 extends from the firstend 251 of motor 250 and is dimensioned to be received within annulargroove 73 of panel 70 and align bore 255 of motor 250 and aperture 75 ofpanel 70. When assembled, motor 250 is adjacent second surface 72 ofpanel 70, thereby isolating the non-sterile motor 250 from the sterilesurgical field. In use, the distal end 210 of the pump 200 is insertedthrough aperture 75 of panel 70 and bore 255 of motor 250. Panel 70 mayfurther comprise a sterile sleeve 60 disposed about aperture 75. If thesterile pump 200 must be removed and placed within the non-sterilefield, sleeve 60 is disposed about sterile pump 200. The sleeve 60protects the sterile pump 200 from contamination within the non-sterilefield, thereby allowing the pump 200 to be replaced within the sterilefield after removal.

In an alternative embodiment illustrated in FIG. 8, panel 70 may furthercontain fittings 90. One such use for fittings 90 is to make aconnection between a blood suction/cell saver apparatus and the surgicalfield. Or fittings 90 may be utilized to supply compressed carbondioxide, oxygen, or saline to the sterile surgical site. These exemplaryillustrations should not be construed as to limit the function of thefittings 90. Fittings 90 may be utilized for many other applications notillustrated. As shown in FIG. 8, panel 70 may further comprise flexiblearm 100 having a first end 105 and a second end 107. The first end 105of arm 100 is adapted to be received by panel 70. The second end 107 ofarm 100 is adapted to receive a surgical device. Arm 100 is,sufficiently stiff therefore allowing the surgeon to adjust the locationof the second end 107 of the arm 100 relative to the surgical site. Asillustrated in FIG. 8 panel 70 may be attached to panel support 78.Panel support 78 is adapted to be inserted under the patient's shouldersand to receive panel 70, thereby disposing panel 70 about the patient'sneck and head region.

As shown in FIG. 9, panel 70 may further. comprise oxygenator 300coupled to first surface 71 of panel 70. Oxygenator 300 comprises fluidinlet 305 and fluid outlet 310. Fluid inlet 305 is in fluidcommunication with pump 200, thereby providing a compact bypass circuitwithin the sterile surgical field. Panel 70 provides a further benefitby moving the pump 200 and oxygenator 300 off of the surgical table,thereby freeing valuable space within the surgical field. An additionalbenefit of the arrangement as shown is that the surgeon may easily viewthe bypass circuit at any time during the procedure.

As shown in FIGS. 3, 9-10, drape 10 may be coupled to panel 70 therebyproviding an assembly 350 that separates the sterile field from thenon-sterile field. Assembly 350 allows pump 200, oxygenator 300, andother medical devices to be placed within the sterile surgical fieldthereby decreasing the overall priming volume of the bypass circuit.Assembly 350 further allows materials and/or devices to be passedbetween the sterile field and the non-sterile field. Panel 70 isconstructed of a biocompatible material such as plastic or metal. In oneembodiment, panel 70 is manufactured of a transparent orsemi-transparent material, thereby allowing theperfusionist/anesthesiologist or surgeon to see through the panel.

While this invention has been described for use in cardiovascularsurgery, this does not limit the applications of this invention for theuse cardiopulmonary bypass surgery only. The invention herein disclosedcan be utilized in other applications apparent to those skilled in theart.

It will be apparent by those skilled in the art that changes could bemade to the embodiments described above without departing form the broadinventive concepts thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but isintended to cover modifications within the spirit and scope of thepresent invention as defined by the appended claims.

1. A surgical drape assembly, comprising: a sterile pump assembly including a non-sterile driving mechanism coupled to the pump assembly by a sterile pump drive cable, a surgical drape having at least one aperture dimensioned to allow the sterile pump drive cable to pass therethrough so as to isolate the non-sterile driving mechanism from the sterile pump assembly located within the surgical field; and a panel structure coupled to said surgical drape adapted to support at least one of said sterile pump assembly and said non-sterile driving mechanism.
 2. The surgical drape assembly of claim 1 and further, wherein said panel structure is further adapted to support a display for displaying information to surgical personnel.
 3. The surgical drape assembly of claim 1 and further, wherein said panel structure is further adapted to support at least one of a suction port coupled to a suction source and a pressure port coupled to a pressure source.
 4. The surgical drape assembly of claim 1 and further, wherein the panel structure is adapted to support a gas port coupled to a least one of an oxygen source and a carbon dioxide source.
 5. The surgical drape assembly of claim 1 and further, wherein said surgical drape is constructed from a generally transparent material.
 6. The surgical drape assembly of claim 1 and further, wherein said panel structure is dimensioned to be positioned between the head and neck region of the patient and the torso region of the patient.
 7. The surgical drape assembly of claim 1 and further, wherein said panel structure is adapted to support at least one of an oxygenator and a fluid reservoir forming part of a cardiopulmonary bypass circuit.
 8. A method of isolating a sterile blood pump disposed within the sterile surgical field from a non-sterile motor disposed outside the sterile surgical field, comprising the steps of: (1) positioning a surgical drape and panel assembly such that a panel structure is positioned between the head and neck region of the patient and the torso region of the patient; (2) coupling said sterile blood pump to the side of the panel structure facing the torso region of the patient such that the sterile blood pump is disposed within the sterile surgical field; and (3) coupling said non-sterile motor to the side of the panel structure facing the head and neck region of the patient such that the motor is disposed outside the sterile surgical field. 